All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present subject matter. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed present subject matter, or that any publication specifically or implicitly referenced is prior art.
Paracentesis, also known as an abdominal tap or peritoneal tap, is a medical procedure involving needle drainage of fluid from a body cavity, most commonly the abdomen. Paracentesis may used for a number of reasons including: to relieve abdominal pressure from ascites; to diagnose spontaneous bacterial peritonitis and other infections (e.g. abdominal TB); to diagnose metastatic cancer; to diagnose blood in peritoneal space in trauma; and to puncture the tympanic membrane for diagnostic purposes, such as taking a bacterial swab from the middle ear.
The procedure is generally performed as an out-patient procedure and although it is considered safe, is often prone to the risk of infection, excessive bleeding or perforating a loop of bowel. During the procedure, patients are prepped and a needle, along with a plastic sheath, is inserted into the abdominal cavity. The needle is then removed, leaving the plastic sheath behind to allow drainage of the fluid. The fluid can be drained by gravity or by connection to a vacuum bottle. The procedure is generally not painful, however, if performed improperly, the needle can puncture the bowel, bladder, a blood vessel, or other organs in the abdomen. The unintentional puncture of adjacent organs may be due to a caregivers inexperience, or lack of mastering proper paracentesis techniques and procedures. As affordable training models are unavailable in the present art, practicing paracentesis training techniques are limited to training on expensive models, which cost upwards of twenty-seven thousand dollars, and are in high demand. Accordingly these models are rarely accessible to medical students and caregivers, leading medical students and caregivers to practice techniques based on the common ‘see one do one’ methodology on human patients. As can be expected, this predominant methodology leads to caregivers with minimal training and experience, and often times apprehensive practitioners and caregivers. Accordingly, the inexperienced practitioners and caregivers may experience higher incidents of complications leading to unnecessary risks, pain and morbidity to the patient.
Accordingly, there exists a need in the art to provide a realistic and affordable method and device for training, practicing and perfecting paracentesis techniques and procedures.
Thoracentesis, also known as pleural fluid aspiration or pleural tap, is the procedure for removing fluid from the space between the lining of the outside of the lungs and the wall of the chest. The procedure involves placing a needle through the skin of the chest wall into the space around the lungs known as the pleural space. Fluid is subsequently withdrawn and collected and may be sent to a laboratory for analysis.
This procedure is indicated when unexplained fluid accumulates in the chest cavity outside the lung. In a great number of cases, analysis of pleural fluid yields clinically useful information. If a large amount of fluid is present, then this procedure can also be used therapeutically to remove that fluid and improve patient comfort and lung function. The most common causes of pleural effusions are cancer, congestive heart failure, pneumonia, and recent surgery.
Complications may occur if the procedure is improperly performed. Even in the presence of an attending physician, inexperienced practitioners and caregivers can place the patient at risk for complications due to poor technique, inability to adequately identify landmarks, lack of experience and improper utilization of a needle-catheter apparatus. Major complications associated with thoracentesis include, pneumothorax, hemopneumothorax, hemorrhage, hypotension (low blood pressure due to a vasovagal response) and reexpansion pulmonary edema. Minor complications include a dry tap (no fluid return), subcutaneous hematoma or seroma, anxiety, dyspnea and cough (after removing large volume of fluid).
Training models currently exist for teaching and practicing thoracentesis, however these models are prohibitively expensive for general use. Models created by Advance Medical Technologies, LLC, and Laerdal, LLC, cost upwards of several thousand dollars, making these models impractical for practitioner or caregiver to own or rent. Even less expensive models such as those provided by Pacific Research Laboratories, Inc., cost several hundred dollars, making it unaffordable for practitioners or caregivers. In addition, several example models are further limited by their inability to make repeated attempts with the standard 8F catheter without causing damage to the model, rendering the models unusable for further procedure training without the purchase of replacement accessories.
Accordingly, there exists a need in the art for an affordable thoracentesis training method and device that enables a practitioner or caregiver to learn and practice thoracentesis procedures.
The lumbar puncture, also known as a spinal tap, is a diagnostic and at times therapeutic procedure that is performed in order to collect a sample of cerebrospinal fluid (“CSF”) for biochemical, microbiological, and cytological analysis, or occasionally as a treatment (“therapeutic lumbar puncture”) to relieve increased intracranial pressure. The most common purpose for a lumbar puncture is to collect cerebrospinal fluid in a case of suspected meningitis, since there is no other reliable tool with which meningitis can be excluded and it is often a lifethreatening but highly treatable condition. Young infants commonly require lumbar puncture as a part of the routine workup for fever without a source, as they have a much higher risk of meningitis than older persons and do not reliably show signs of meningeal irritation (meningismus). Lumbar punctures may also be performed to inject medications into the cerebrospinal fluid (“intrathecally”), particularly for spinal anesthesia or chemotherapy.
The procedure is performed by first placing the patient in a left (or right) lateral position with his/her neck bent in full flexion and knees bent in full flexion up to his/her chest, approximating the fetal position. Once the appropriate location is palpated, local anesthetic is administered under the skin and then injected along the intended path of the spinal needle. A spinal needle is inserted between the lumbar vertebrae L3/L4 or L4/L5 and pushed in until there is a “give” that indicates the needle is past the dura mater. The stylet from the spinal needle is then withdrawn and drops of cerebrospinal fluid are collected. The procedure is completed by withdrawing the needle while placing pressure on the puncture site.
Current methods for training of this procedure are usually done on the patient guided by experienced supervising physicians. Incorrect techniques resulting from inadequate training or supervision can result in sub-optimal outcomes, unnecessary pain and suffering by patients. Although serious complications of an inproperly performed lumbar puncture are extremely rare, they include spinal or epidural bleeding, and trauma to the spinal cord or spinal nerve roots resulting in weakness or loss of sensation, or even paraplegia. In addition there are case reports of lumbar puncture resulting in perforation of abnormal dural arterio-venous malformations, resulting in catastrophic epidural hemorrhage.
Although there are current training models for teaching and practicing a lumbar puncture, these models are prohibitively expensive for general use and cost upwards of several thousand dollars, making the models impractical for practitioner or caregivers to own. For instance, Simulution provides a spinal injunction simulation training model (http://www.simulution.com/shop-online/spinal/spinal-injection-simulator) which is a bare-bones training device, costing nearly one-thousand dollars.
Consequently, there exists a need in the art for an affordable lumbar puncture training method and device that enables a practitioner or caregiver to learn and practice lumbar puncture procedures.